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NCT06559176 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Efficacy of Prime Editing (PM359) in Participants With p47phox Autosomal Recessive Chronic Granulomatous Disease (CGD )
A Phase 1 study of Chronic Granulomatous Disease and Granulomatous Disease, Chronic, sponsored by Prime Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 5
- Study locations
NCT06559176 is a Phase 1 study of Chronic Granulomatous Disease and Granulomatous Disease, Chronic that is active but no longer recruiting, run by Prime Medicine. The registered enrollment target is 12 participants, below the 32-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (62% lower). The trial reports 5 study locations across 5 states.
The verdict
NCT06559176, a Phase 1 study of Chronic Granulomatous Disease and Granulomatous Disease, Chronic, is active but no longer recruiting, sponsored by Prime Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is an open-label, single-arm, multicenter Phase 1/2 study evaluating the safety and efficacy of gene therapy by transplantation of Prime Edited autologous CD34+ stem cells modified ex vivo (PM359) in participants with autosomal recessive Chronic Granulomatous Disease (CGD) caused by mutations in the NCF1 (Neutrophil Cytosolic Factor 1) gene.
Conditions Studied
Interventions
- BIOLOGICAL PM359
Study Locations (5)
California
- University of California Los Angeles Medical Center - Los Angeles
Maryland
- NIH Clinical Center - Bethesda
Tennessee
- The Children's Hospital at Tristar Medical Group/Sarah Cannon Center for Blood Cancers - Nashville
Quebec
- CHU - Sainte Justine Hospital - Montreal
England
- University College of London Hospital - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-10-17 |
| Est. Completion | 2030-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06559176
The ClinicalTrials.gov registry entry for NCT06559176 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 32-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (62% lower). The listed sponsor is Prime Medicine, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Granulomatous Disease appearing as the primary indexed condition, and to 1 intervention - of which PM359 is the first listed.
NCT06559176 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Maryland, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06559176 about?
NCT06559176 is a clinical study titled "A Study of the Safety and Efficacy of Prime Editing (PM359) in Participants With p47phox Autosomal Recessive Chronic Granulomatous Disease (CGD )". This is an open-label, single-arm, multicenter Phase 1/2 study evaluating the safety and efficacy of gene therapy by transplantation of Prime Edited autologous CD34+ stem cells modified ex vivo (PM359) in participants with autosomal recessive Chronic Granulomatous Disease (CGD) caused by mutations i...
What is the current status of trial NCT06559176?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-10-17. Estimated completion is 2030-02.
What conditions does trial NCT06559176 study?
This clinical trial studies the following conditions: Chronic Granulomatous Disease, Granulomatous Disease, Chronic.
What interventions are being tested in trial NCT06559176?
The interventions under investigation include: PM359 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06559176?
This trial is sponsored by Prime Medicine, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06559176 being conducted?
This trial has 5 study locations across California, Maryland, Tennessee, Quebec, England. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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